Inclisiran (Leqvio)

Key Messages

• CADTH recommends that Leqvio should not be reimbursed by public drug plans as an adjunct to lifestyle changes, including diet, to further reduce low-density lipoprotein cholesterol (LDL-C) levels in adults who are on a maximally tolerated dose of a statin, with or without other LDL-C–lowering therapies, and who have heterozygous familial hypercholesterolemia (HeFH) or non-familial hypercholesterolemia (nFH) with atherosclerotic cardiovascular disease (ASCVD).
• Evidence from 3 clinical trials showed that treatment with Leqvio lowered bad cholesterol (LDL-C) in adults with HeFH or nFH with ASCVD who were already being treated with the highest possible dose of statins and in those who cannot tolerate treatment with statins.
• Patients identified a need for treatments that can reduce bad cholesterol (LDL-C) and cardiovascular morbidity and death; however, there was not enough evidence to show that Leqvio would reduce cardiovascular morbidity and death. Results from 2 ongoing studies (ORION-4 and ORION-8) will contribute valuable information regarding the long-term safety and efficacy of Leqvio when results become available.